HIGH

B Braun Medical IV Administration Set Recall Affects 41,976 Units Worldwide (2025)

B Braun Medical recalled 41,976 IV Administration Sets sold worldwide after identifying a backflow risk. The device can allow medication to flow from secondary (piggyback) containers into the primary IV line and may not prime properly. Hospitals and healthcare providers should stop using the sets immediately and await recall instructions from B Braun Medical.

Quick Facts at a Glance

Recall Date
October 29, 2025
Hazard Level
HIGH
Brand
B Braun Medical
Category
Health & Personal Care
Sold At
Multiple Retailers
At-Risk Groups
GENERAL

Hazard Information

Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact B Braun Medical Inc or your healthcare provider for instructions. Notification method: Letter

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About This Product

IV administration sets are used to deliver fluids and medications through IV lines in hospital and clinical settings. They connect to IV bags or pumps and are selected based on compatibility with infusion devices.

Why This Is Dangerous

Backflow into the primary IV line can lead to medication misadministration or contamination. Inability to prime can disrupt flow and dosing.

Industry Context

This recall is not described as part of a broader industry pattern in the provided information.

Real-World Impact

Hospitals and clinics may need to quarantine affected lots and switch to alternatives, impacting inventory and workflow.

Practical Guidance

How to identify if yours is affected

  1. Verify Catalog Number 490354 on the device label.
  2. Check Primary UDI-DI 04046964602382 and Unit of Dose UDI-DI 04046964602375 on packaging.
  3. Review the recall notice sent by mail for instructions.

Where to find product info

UDI numbers, catalog numbers, and expiration on device packaging and recall notices.

What timeline to expect

Refunds or replacements typically take 4-8 weeks after submission of the recall claim.

If the manufacturer is unresponsive

  • Document all attempts to contact the manufacturer.
  • File a complaint with the FDA or relevant health authority if the company remains unresponsive.
  • Consult legal counsel if necessary.

How to prevent similar issues

  • Verify device compatibility with infusion pumps before purchase.
  • Maintain an updated inventory of IV sets and verify backflow prevention features.
  • Follow all device recalls promptly.
  • Check for any new recall notices from the manufacturer.

Documentation advice

Keep recall notice, purchase records, batch/lot numbers, and correspondence with the manufacturer as part of the record.

Product Details

Catalog Number: 490354. Primary UDI-DI: 04046964602382. Unit of Dose UDI-DI: 04046964602375. Expiration Date: Earliest Exp of Comp or 24mths. Distribution: Worldwide, including US, Canada, Germany, Guatemala, Singapore. Quantity: 41,976 units. Brand: B Braun Medical.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 41,976 units recalled
  • Catalog Number 490354
  • Primary UDI-DI 04046964602382
  • Unit of Dose UDI-DI 04046964602375
  • Distribution: Worldwide (US, Canada, Germany, Guatemala, Singapore)
  • Hazard: backflow and occlusion risk

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
POISONINGELECTRICALLACERATIONSUFFOCATIONOTHER

Product Details

Model Numbers
Catalog Number: 490354
Primary UDI-DI: 04046964602382
Unit of Dose UDI-DI: 04046964602375
Report Date
December 3, 2025
Recall Status
ACTIVE

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